Medical Device Design: Innovation from Concept to Market

Medical Device Design

Innovation from Concept to Market

Second Edition

Peter Ogrodnik

Table of Contents

Cover image

Title page

Copyright

Dedication

Preface

Acknowledgements

Chapter 1. Introduction

1.1. The medical devices world since 2012

1.2. What is design?

1.3. Summary

Chapter 2. Classifying medical devices

2.1. Why classify?

2.2. Classification rules

2.3. Classification case studies

2.4. Further case studies

2.5. Classification models

2.6. Classification and the design process

2.7. Classifying software

2.8. Impact of classification on conformity assessment

2.9. Summary

Chapter 3. The design process

3.1. Design process v design control

3.2. Changes since the last edition

3.3. Design models

3.4. Managing design

3.5. Cross-reference with regulatory requirements

3.6. Summary

3.7. Tasks

Chapter 4. Implementing design procedures

4.1. Introduction

4.2. Review of guidelines

4.3. Overall procedure

4.4. Audit/Review procedure

4.5. The design process

4.6. Implementing a procedure

4.7. Summary

Chapter 5. Developing your product design specification

5.1. Introduction

5.2. Developing the statement of need (or brief)

5.3. The product design specification (PDS)

5.4. Finding, extracting and analysing the content

5.5. Devices containing electronics or electrical power

5.6. Software

5.7. Summary

5.8. Homework

Chapter 6. Generating ideas and concepts

6.1. Introduction

Chapter 7. Enhancing quality in design

7.1. Introduction

7.2. Why quality in design?

7.3. Optimization

7.4. 2k Factorial experiments/design of experiments

7.5. House of quality

7.6. Failure mode and effect analysis (FMEA)

7.7. Fault tree analysis

7.8. Ishikawa diagram

7.9. D - 4 –X

7.10. Six sigma

7.11. End user input

7.12. Talk to your suppliers

7.13. A word about software development

7.14. Summary

Chapter 8. Design realisation/detailed design

8.1. Introduction

8.2. The process to design realization

8.3. Assemble your detailed design team

8.4. Design calculations

8.5. Materials selection

8.6. Computer aided design

8.7. Component selection

8.8. D-4-X

8.9. Summary

Chapter 9. Risk management, risk analysis and ISO 14971

9.1. Introduction

9.2. Risk management

9.3. Risk analysis

9.4. Identifying risks/hazards

9.5. Assessing level of risk

9.6. Risk management procedure document

9.7. Risk management folder in the technical file

9.8. Risk management and internal procedures

9.9. Software

9.10. Standards, courses and certification

9.11. Summary

Chapter 10. Evaluation (validation and verification)

10.1. Introduction

10.2. Reporting of evaluations

10.3. In-Vitro evaluations

10.4. In silico

10.5. In-vivo

10.6. Presenting the outcomes of your evaluation

10.7. Value to ‘healthcare’ analysis

10.8. Summary

Chapter 11. Manufacturing supply chain

11.1. Introduction

11.2. Identifying potential suppliers

11.3. Packaging

11.4. Procurement

11.5. Summary

Chapter 12. Labeling and instructions for use

12.1. Introduction

12.2. Standard symbols and texts

12.3. Labeling

12.4. Marking

12.5. IFUs and surgical techniques

12.6. Surgical technique

12.7. Declarations

12.8. Translation

12.9. Software and items with electrical power

12.10. Summary

Chapter 13. Post market surveillance

13.1. Introduction

13.2. PMS and its role in design

13.3. Tools

13.4. Using your existing contacts

13.5. Vigilance

13.6. The good, the bad, and the ugly

13.7. Summary

Chapter 14. Protecting your IP

14.1. Introduction

14.2. Types of IP protection

14.3. Keeping mum

14.4. Talking with partners

14.5. Summary

Chapter 15. Obtaining regulatory approval to market

15.1. Introduction

15.2. Class I devices

15.3. Higher classifications

15.4. FDA process

15.5. EU process

15.6. Getting to market

15.7. Summary

Appendix A. Useful websites

Appendix B

Appendix C

Appendix D

Appendix E

Appendix F. Further worked examples of a PDS

Index

Copyright

Academic Press is an imprint of Elsevier

125 London Wall, London EC2Y 5AS, United Kingdom

525 B Street, Suite 1650, San Diego, CA 92101, United States

50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States

The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom

Copyright © 2020 Elsevier Ltd. All rights reserved.

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions.

This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

Library of Congress Cataloging-in-Publication Data

A catalog record for this book is available from the Library of Congress

British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from the British Library

ISBN: 978-0-12-814962-1

For information on all Academic Press publications visit our website at https://www.elsevier.com/books-and-journals

Publisher: Mara Conner

Acquisition Editor: Fiona Geraghty

Editorial Project Manager: Fernanda A. Oliveira

Production Project Manager: R.Vijay Bharath

Cover Designer: Christian J. Bilbow

Typeset by TNQ Technologies

Dedication

I would like to dedicate this book to the three most important people in my life – my wife Lynda and my two daughters Natasha and Zoe. I would like to thank them for helping me to get me through a couple of tough years.

Whatever happens always happens for the best.

Preface

I am sorry if this seems familiar, but the story for this book has not really changed. The first edition of this book fulfilled an ambition I held for many years. When I first started on the medical engineering pathway I was so disappointed that there were no texts to help me to design a device – the bookshelves were empty. There were loads of books available to tell me how to measure the angle of an ankle joint, or even how to use an X-ray machine… but could I find one telling me how to design one? No. Luckily my background is in mechanical engineering and good design practice was forced into me so adhering to medical devices regulations was relatively easy. However I was dismayed when I looked back and saw how much time I had wasted trying to make the basic design principles fit into the regulatory framework.

When I started Edition 1 I first visited the bookshelves again (only now Mrs Hubbard's cupboard was electronic and web based). Once again I was dismayed that little progress had been made. The regulatory bodies themselves had come up with some guidelines, but all of the biomedical engineering books had followed the same old path. It was at this point that my ambition was rekindled and I decided to contact the publisher of my first book to see if they were interested in having a medical devices design handbook in their portfolio. Unfortunately it was out of their scope but they gave me a name of someone they knew who may be interested. I therefore, with some trepidation, sent a brief proposal to this person. Little known to me was that he was, at that very moment, in a meeting in the USA discussing the need for a medical devices design handbook with his colleagues, and they were trying to think who could write it – his email went ping and their was my proposal. Serendipity does throw up some unlikely coincidences – and this was one of the best.

Back to the story. After a frantic email exchange I set about designing THE medical devices design handbook; only to realize that I was probably doing the same as others before me – ignoring the fact that this is about design in a medical devices environment, not just biomedical engineering. I soon came to realize that the best approach would be to start from the beginning (in design terms) and assume all readers (no matter what background) have a poor design education and to take things step by step. Once I had identified this simple seed of an idea, the book fell into place. In fact, I had actually designed the book not just written it. I decided that the format for the text must be informal; it must have the feel of a conversation rather than the usual, dry – sometimes pompous – nature of textbooks. I hope I have achieved this (not the pompous bit!). The main layout of the book is bite-sized, self contained, chapters that you can read or not read as you choose. So, for example, if you are happy with your knowledge of labeling there is little need for you to spend hours reading that chapter… but you may spend more time on specification development. Oh, while we are on that subject DO NOT ignore the specification chapter, this is the core of all good design practice. Miss out this chapter and I (or your patients) may come back and haunt you! Also DO NOT miss the RISK chapter either – I am often amazed how few people can perform this so simple task.

The good news is that my suspicions that gave me the idea that there was a need for this book was justified. Edition 1 was highly successful. Hence there is a distinct need for updating it and improving it (based on some of your comments) to create Edition 2.

Since edition 1 there have been many regulatory changes. I have tried to take these into account in the text. I do hope I have managed to do so. In essence the main message has not changed; but what has changed is the way in which you are expected to present your work and some essential steps you must not miss out. I hope I have shown these changes due regard, and done them justice. Also I have included more case studies, and much more content on electronics/software. I hope these elements are useful.

So, if you are an established design engineer, an entrepreneur, or a surgeon with a brainwave the book will help you to take your idea to the next level. It may simply enable you to communicate with a designer with a better outcome, or it may help you to take your product to FDA clearance to market; it may even reduce your time to market. Whilst I would love to claim that use of this book would mean that all of your designs would meet every regulatory requirement I cannot. What I can say is that it will give you the ability to make sure that you know which ones you have to meet; and gives you the toolkit and the basic design principles to be able to meet them. Of course I would love to hear of your successes. I am sure emails to the publishers, via their website, will get to me.

To close this preface, I wish to reiterate my aim. This book is targeted at those who wish to design a medical device for sale within the global medical devices community. Be that a simple scalpel, or an MRI scanner. It is intended to be a reference text that will be on your desk, right next to your IPad and cellphone. Ah, that reminds me; I must apologize to those in the UK. The publishers of this book are USA based and hence spellings are USA based, so if you see a ‘z’ were there should be an ‘s’, or if a ‘u’ is missing, or I say cellphone instead of mobile ‘phone, then I am sorry but that is the way of the textbook market nowadays. Equally, for those of you in the USA if you do not follow some my footnotes then treat them as British idiosyncrasies and laugh out loud (as my editor did!). However, wherever possible I have tried to cross the pond – as they say – by including US English, UK English and EU cross-references (wherever possible). I hope they work.

Good luck with your designs; may they make patients feel a lot better and make your bank balances a lot healthier.

PJO

England. January 2019

p.s. As with most handbooks the text is only a guide. Following its contents does not guarantee any degree of success, performance or safety – only YOU can do that.

Acknowledgements

I would like to thank the following for their kind assistance in the production of this book by allowing me to use photographs, case studies and general information: Metaphysis LLP; Riverway Medical Packaging Ltd; DeSoutter, Stratasys, and Keele University. Furthermore, the US Food and Drugs Administration (USA) and the Medical and Healthcare products Regulatory Agency (UK),BSI, TÜV (and other Notified Bodies) require acknowledgement as their respective online repositories were a mine of information. I also thank all those who have given me advice along the way especially Prof Peter Thomas, Mrs Susan Hartman, and (of course) my editorial team at Elsevier; if I have forgotten anyone please forgive me.

Chapter 1

Introduction

Abstract

In this chapter the regulatory framework for medical devices is introduced. The old Medical Devices Directive is compared with the new Medical devices Regulations, and CFR21 and the FDA are introduced.

Keywords

MDD; MDR; IVD; FDA; CFR21; Medical Device

Plus ça change, plus c'est même chose ¹

Jean Baptiste Kerr (1849).

1.1. The medical devices world since 2012

Before we get into the book its is worth noting that since the first edition was published in late 2012 the medical devices world has changed. Let us explore some to of the changes.

Just as a word of warning, some things have changed for definite (e.g. ISO 13485), some things are coming into force at a much later date (e.g. the new Medical Devices Regulations), and some things we have no idea about but will have an impact (e.g. Brexit). I will try to be as clear as possible throughout so that you, the reader, still have a basis on which to operate.

1.1.1. What has changed since Edition 1

There have been three major changes in medical devices land since edition 1 was published.

The first is the new ISO 14971 ² (the risk management standard for medical devices) which was published in 2012. This is the version everyone should be using now.

In 2016 the new ISO 13485 (the quality management standard for medical devices) was published and everyone must have transitioned by Spring (2018). Hence, by the time you are reading this, everyone should be using it. This one is a good change as it harmonises across boundaries, so the FDA accept ISO13485:2016 as do the EU.

Finally the European Unions's new Medical Devices Regulations 2017/245 have just been published and everyone must have transferred over by 26th May 2020 from the old Medical Devices Directive to be compliant.

Throughout this text I will try to point out what has changed and what has not. Equally the FDA have been tweaking rules and regulations too, but nothing as major as a totally brand new set or rules. Keeping up to date has never been so important!

One major important imminent change is Brexit. No one really knows what the implications are for the medical devices industry in the UK or even the market place. But we do know that if we are to sell devices into the EU and the USA we must still follow the EU and FDA rules. What actually happens in the UK will, hopefully, become clearer but importance of design control will, inevitably, remain the same as ISO14971 and ISO13485 are international standards so they have to be followed – no questions.

1.1.2. The internet of things and big data

There can be little doubt in anyone's mind that technology has moved on a pace in the last few years. What was only a dream in Star Trek ³ in the 60's is now a reality (i.e talking to a computer). The use of internet technology to enable devices to communicate with each other, and share data is a reality. Satellite communications has enabled whole countries to become internet ready. And, finally, 5G mobile networks will revolutionise the way we use our mobile (sorry cell) phones – once again.

Embedding software, IoT technology, and big data in medical devices is already starting. Certainly by the time you read this book more than one Internet of Medicine device will be in the market place. To some extent the USA and the FDA have embraced this challenge. The EU, in respect, have still to grasp the nettle rather than regulate against its eventual existence.

1.1.3. The medical devices police

Before we go too far it is important to introduce you to the Police Forces ⁴ of medical devices. It is worth thinking of them as police because they have the power of life and death over your device and your company.

In Europe each country has their own government body called the Competent Authority. Even though they are separate bodies they act as one so that an application for a CE mark (the license to sell with the European Union) in one country counts in all of the other member states. The process is somewhat confused by the next level called the Notified Body; these are legal entities who are licensed by the Competent Authority to do the CE marking process. These are the people that an applicant would speak too and would be audited by. This is completely different in the USA; here the body is the US Food and Drugs Administration (FDA) and the relevant subset is the Center for Devices and Radiological Health (CDRH). The applicant talks direct to the FDA (via CDRH) and obtains a Clearance To Market (DO NOT use any other words).

It is important to know that the applicant / holder of the CE mark or FDA clearance to market is universally known as the Manufacturer ⁵ and they are the top of the regulatory food chain and are ultimately responsible for the Safety of said device (the designer, the subcontractor the packager etc are subservient to them). However all are a part of the regulatory process (as we will see later). With manufacturer status comes further levels of responsibility, and is not just about insurance. It brings in reporting, vigilance, post market surveillance, gathering clinical evidence and much more. Some are beyond the scope of this book, but they will be referred to as necessary.

Canada has her own level of complexity (with CAMDCAS), and Japan's is even more complex. However, the main thing to learn here is that the application processes are as different as they could possibly be - but at the end of the day the application is about how you present your design to the authorities; how you do your design is always the same, wherever you are!

At this stage it is worth discussing liability. Ultimately it is the manufacturer who has the ultimate responsibility for liability. However, as with any other discipline, their insurers will try and pass liability down the food chain. Hence it is important, when acting as a sub-contractor, that you have relevant insurance in place – and that you never exceed your own level of experience. But, as the designer, one is the hub of the activity. Without the designer nothing happens, no device exists and there is nothing to present for sale. Hence the product lives and dies at your hands, so your knowledge of the medical devices regime is fundamental. Your adherence to the structured design processes is essential, and your communication with others is of paramount importance. That is why Fig. 1.1 has the graphics of a new baby, this is just how the medical device designer must picture their device. It must be treated with the care and diligence one would apply to a new-born baby; it is, after all, your baby.

1.1.4. Essential definitions and how they have changed

As discussed earlier it is important to be embedded in the discipline in which you practice design. Hence a car designer is embedded within the automotive industry, probably plays with their own car at night and weekends; almost certainly watches or takes part in motor-sport; and will read every car magazine under the sun. So it is with the medical devices designer: we must tinker, read, observe and play … but unlikely that we will ever be able to use our designs. Hence we operate (excuse the pun!) remotely, but we also know that one day our design may just come and save us too. The lesson here is that we need to know as much about the end use as the end-user. In fact we need to know more than the individual end-user, we need to consider all end users. I can promise you that if you understand your discipline well then your designs will be good and you will get great satisfaction in knowing that you have saved someone's leg, eye or life.

However, the corollary is that you can also contribute to the loss of someone's leg, eye or life. To these end medical devices is one of the most highly regulated arenas to work in. And the first staging post is to fully understand what a medical device is. Believe me that this is one of the hardest battles you will have with your end-users. Each one will think they are a special case and are, somehow, excluded – they are not and neither are you. More importantly you are the one who will end up in court.

The European Union and FDA have tidy definitions of a medical device. Within Europe this was laid down in law under the Medical Devices Directive 93/42/EEC as amended (most recently) by 2007/47/EC. This definition is in force until Spring 2020:

a) ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment or alleviation of disease,

- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

- investigation, replacement or modification of the anatomy or of a physiological process,

- control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

EC (1993).

I would propose that this is pretty clear; if the device is to be used in any clinical environment, on humans, then it is a medical device. Note it does not say that the device has to be in a hospital or used by a clinician - it is defined by intended use. The intended use is your wording; get it wrong and you can end up in a whole heap of trouble, get it right and your life can be a whole lot easier – regulatory wise. We will spend a lot of time on intended use.

The new Medical Devices Regulations 2017/745 (to make life easier I will refer to this as MDR from now on)come into force in May 2020 (we have two years to change over) and the new definition is:

medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

EU (2017a) ⁶ .

The following products shall also be deemed to be medical devices:

— devices for the control or support of conception;

— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

As you can see the definition has grown somewhat! But it is essentially the same, just more explicit so that some ‘gray area’ devices do not fall through the net – in particular software!

Compare this with the equivalent definition from the USA (taken from the Federal Food, Drug, and Cosmetic Act - FD&C Act):

The term device (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

FDA (2018).

As with the EU the FDA have updated their definition of a medical device: note the last paragraph.

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term device does not include software functions excluded pursuant to section 520(o).

Note that both EU and FDA clearly distinguish between a device and a pharmacological agent. Also note that the FDA have a much more detailed analysis of the role of software in medical devices (FDA, 2017). Do download a copy of 520(o) if you have any software associated with your device.

Often devices need accessories or additional items for particular functions, these are covered too:

b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;

EC (1993).

And the MDR definition:

accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

EU (2017b).

The importance of accessories will become more pronounced as we go further into the design process. Some people saw accessories as being devoid of regulatory control, as some form of get out clause. The new MDR has tightened this up.

Or if your design is to be used with something from definition (a) then it too is a medical device. Again, this is pretty clear. What about things used in a laboratory for assessment of things taken from the human body, and not necessarily in contact with said body? Once again it's covered:

(c) ‘device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;

EC (1993, 1998).

But in the new regulations in-vitro diagnostic devices have their own special regulation EU 2017/746: and in that regulation the definition is:

in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

(a) concerning a physiological or pathological process or state;

(b) concerning congenital physical or mental impairments;

(c) concerning the predisposition to a medical condition or a disease;

(d) to determine the safety and compatibility with potential recipients;

(e) to predict treatment response or reactions;

(f) to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

EU (2017a).

The perennial question comes from the large made for the patient market. Some see this as an escape clause or a loophole; it is not.

(d) ‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.

EC (1993).

What it does do is allow for custom made devices to exist but without the pre-market assessments required for mainstream devices. Some people have used this loophole to death, as such the EU have tightened this definition to exclude wholesale misuse:

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;

EU (2017b).

If this definition were not there then any custom devices could not exist; it does not mean that the design rigor is any less stringent. It definitely does not mean the medical practitioner takes the blame for any problems – they are not designers or engineers; you still carry the can for any design issues. Note the last paragraph!

The next definitions are to do with power source, or to do with higher risk functions:

‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

EC (1990).

‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

EC (1990).

Once again the new regulations have made changes. Most significantly active devices are now a part of the new MDR:

‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Software shall also be deemed to be an active device;

EU (2017b).

Note the significance of software. Sorry all you computer scientists and software engineers you cannot hide behind the words agile and adaptive anymore – you HAVE to follow design control rules.

The last piece of the jigsaw, though, is the new definition of an implanted device:

‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:

— to be totally introduced into the human body, or

— to replace an epithelial surface or the surface of the eye,

by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30   days shall also be deemed to be an implantable device;

EU (2017b).

Once again these are very clear. I hope you noticed that it is the distilling of the legal wording into small chunks that has made these definitions understandable. Seeing them on a single sheet is daunting. Throughout this book I aim to present the important issues in this manner.

The lesson, however, is - no matter which of the above definitions your device falls into then do the right things and follow a structured procedure. It is important to note that they are all Medical Devices and are all governed, ultimately, by that definition.

However, as technology advances some products and processes become more dangerous than they were before. So there are two issues we designers have to consider – the first we need to keep in constant touch with these important definitions – the second we need to keep up to date with advances in medicine and technology.

There are a number of other requirements you need to be aware of too. In medical devices there are sub-disciplines that you need to make sure you work with. Until 2020 you can refer to Active Implantable Devices (AID) (90/385/EC), and In-Vitro Diagnostics (IVD) (98/79/EC), but you may as well start to think about the two new Medical Device Regulations. However at the time of writing this book there was only one Notified Body licensed to assess to the new MDR – so you should not jump too quickly. So a quick rule of thumb, up until Dec 2019 the old MDD and its associated IVD and AID directives will be adequate, but the closer we get to the End of 2019 the more you will be expected to be working more closely to the new MDR. Hence I will be trying to demonstrate how the transition from one to the other should be painless. But I will not discount the old MDD as this would be folly for this edition.

Remember your product may also fall foul of other directives, such as Electro-Magnetic Compatibility (EMC) or even Powered Tools. There will also be other standards that your device might have to adhere to. Hence the rule here is have a copy of any legislative document you may think you will need to hand, they are free to download from the websites so there is no excuse. A list of important links can be found in Appendix A of this book; however you should make sure you keep your own list and keep it up to date as the documents change, rapidly. Then, you can omit them in the design process, and at your leisure. We will be looking at this in more detail when we cover Classifications – that is putting your device within the correct pigeon-hole for regulatory requirements. In the end, so long as you do your design work correctly the classification is immaterial, as a designer should treat every design with the same care; but it does influence some of your decisions.

What have we learned from this section? All has changed since 2012. If you have a device in the market place check that you have not moved from not being a medical device to being a medical device – or even vice versa. Whatever the outcome following design control principles will only make your products better – so why do otherwise?

1.2. What is design?

In most people’s vocabularies, design means veneer. It’s interior decorating. It’s the fabric of the curtains of the sofa. But to me, nothing could be further from the meaning of design. Design is the fundamental soul of a human-made creation that ends up expressing itself in successive outer layers of the product or service.

Steve Jobs (2000).

The word design causes confusion in every circle of life. One can use design as a noun … this is my design; as a verb … I am designing and, even worse, is the question …. are you the designer?.

Design comes from the Latin ‘designare’ – to mark out, point out, describe, contrive. Its form as a noun is the source for the common misconception: it is ‘a design’ is normally attributed to a pattern or an image. If you stop an average person in a street and ask them to describe a designer, they are more likely to talk about wallpaper, clothes, hats or tableware than, say, someone who designs, say, a total hip replacement. In this text we are more concerned with the verb – to design, the act of designing, the act of contriving and communicating the contrivance. The phrase "to design" is very important. It suggests some formality, some structure, and some rigor. As far back as the 1960's the UK government commissioned (by the then Lord Hailsham) a committee to oversee design in mechanical engineering education. It came up with the following definition:

(mechanical engineering) design. is the use of scientific principles, technical information and imagination in the definition of a (mechanical) structure, machine or system to perform pre-specified functions with the maximum economy and efficiency.

HMSO (1963).

What a wonderful definition of design! All I would add are the words ingenuity and specific background knowledge into the list and it would be complete.

We recognise a contrivance, structure, machine or system as a product; something we are going to sell to someone else. In this sense the product could be an item, a piece of software or a service. Practically, it is virtually impossible to design something that is not intended to be useful to someone. Indeed, being able to design is what makes humans so … so human. We are able to manipulate our surroundings to make it better for us, and we can do some pretty wonderful things with items that are, inherently, rocks and trees. Hence, I propose, that designing is in our blood … it comes as second nature to the human race. But as with other things we humans do, some of us are naturally good at it and some of us are not.

It is a common tendency for us to ‘hack’ – that is we undertake the activity without any plan or thought. Hence we hack at the problem; just like hacking at an overgrown bush with an axe. Hacking achieves an outcome, but one that has wasted loads of energy and the outcome is, always, pretty awful. Hacking is also an illegal activity associated with breaking into high-security computer systems; so, to coin a phrase, "neither hack nor a hacker be". ⁷ The aim of the phrase to design is, therefore, a reminder to us all that we need to plan and think about the problem before we start; and definitely not ‘hack’.

So, what are we to deduce from the paragraphs above? Firstly design is a creative activity – it always ends with something new. On its own, however, this is not design – it could also be a work of art or the breaking of a world record. Hence we need to add something else. That something else is a demand, or a need - someone, somewhere wants this thing. Again this could still be a work of art or a new world record. We still need to add one other thing; that is a planned structure; a route map; or a planned process. This now discriminates the activity from all others. If you design an artifact properly someone, somewhere will definitely like it and it will be sold. And this is why the word design is often confused with the arts – it is a creative process. But creativity without structure is not design. As designers we need to harness our creative juices; stimulate every analytical fiber in our bodies; and use every one of our senses to detect opportunities. But we need to do this within an overall structure to ensure that the final outcome meets a need. Hence a modified definition of ‘design’ could be:

Design. is the use of scientific principles, technical information, imagination, ingenuity and specific background knowledge to define a product (be that a structure, machine or system) to meet a well defined need with the maximum economy and efficiency.

It is clear that we, now, need to define the need as this seems to be core to the any design activity - and so it is. Design is about producing something that someone wants. They may not know they want it, but they do want it. How many times have you been to a clothes shop looking for a particular tie, blouse or shirt? You will have a picture in your mind of what you want – that is your need. If the clothing designers have been clever they will have anticipated your need and you buy it. Normally, however, we walk from shop to shop and go home unhappy with something close, but not quite right. So many consumer goods are based on this ‘predictive’ design process – the designers forecast what the consumer will need in, say, a year's time (based on market research) and devise what the need will be; or even create a need through fashion trends (how many fashion shows and magazines are there?). Another example of this type of prospective need is when technology is rapidly developing and a brand new concept comes from nowhere – e.g the Sony Walkman – this is often called disruptive technology (a new technology which completely changes the way things are done). The Walkman was a success because there was a brilliant forecast that the consumer would want this – but how many disruptive technologies wither on the vine? We do not hear about them because they failed – Sinclair C5 anyone ⁸ ?

There is, of course, the immediate response to a demand from the consumer. This is synchronous or immediate need. This is where the designer is, physically, asked to develop a design based on a direct request. Classic examples of this are buildings – if you ask for your own house to be designed you will be working so close with the designer / architect that the information flow is, effectively, synchronous. This is the hardest to manage as the results are, often, needed immediately too.

The reverse process retrospective or evolutionary need is another name for evolutionary design. It is based on previous designs that may need improvement by implementing a small change. It is, nearly, always based on an existing concept but a small change makes it different, more desirable, or to counteract an issue. It is often based on customer feedback.

The final form is scavenging need. This is like watching vultures or carrion crow feeding on a dead animal. Here the need is not to produce something new but to produce something similar. Often seen in the fashion industry and in consumer goods by those who follow but do not lead. This is commonly known as me too. It is said that imitation is the best form of flattery – one would rather be ‘the flattered’ then ‘the flatterer’. It is, of course, intrinsically linked with copying and counterfeit.

Defining the need is, clearly, very important. We will be examining the need and how to articulate it in more detail in subsequent chapters. This may not seem a creative process, but it is. More often than not, this is the hardest part of the design process. It is hard because we need to understand the customer, fully. But, and this I can promise, if done properly the rest of the process will be so much easier.

So – is defining the need design? The previous paragraph should have pointed you to the fact that it is the start of the process. What follows next is the highly creative phase called ideas generation. We then have to select a winner from the plethora of ideas we have generated; and then we need to the detail (or the embodiment). Only when that is done do we have the makings of a design. But, as we will see later, we have not finished, as we still need all of the other elements: packaging; instructions for use; etc., etc., etc. Only when all of this is complete do we have a design.

So, what is design? The simple answer is.

It is a process that takes a need and produces the solution that fulfills said need.

And, what is a design?

It is the solution.

Unfortunately we now come to the hard bit. We need to put all of the rhetoric into action; and as with most human activities it is easier said than done. The rest of this book is here to make this a lot easier for you.

1.2.1. The design life cycle

People like to talk about the life of a design. To have a life means something has to be brought to life and then die; clearly this is a little too anthropomorphic for comfort. But the idea of a cycle is very important and the product's ‘conception’; ‘birth’; and ultimate ‘end of life’ is very pertinent to the designer. In the past the cycle was only concerned with the time to bring new versions to market (revision cycle). Nowadays we consider the whole cycle from manufacture to disposal for obvious environmental reasons. Hence we have two cycles to consider, revision cycle analysis and life cycle analysis. To avoid confusion between the old and the new, we will use these two terms from now on.

Revision cycle analysis is concerned with keeping products and services ‘up to date’ – and this is usually reflected by sales figures. A classic bath-tub curve describes this cycle (Fig. 1.1). At the beginning a new design generates new interest and the sales grow. Eventually these sales plateau as market penetration is reached; consumers get bored, new competitors come along or there is no one left to sell to. Hence this design's life has ended. To carry on with this version would be silly top say the least. Hence designers need to plan revisions into the process to keep the plateau sales going (Fig. 1.2). Hence it is important to understand why a design is never finished … it goes on and on, continually improving, continually getting better. In quality management this is called a continual improvement process. It is clear that unless the designer is embedded into the discipline into which their design will reside all will fail.